National Biospecimen Network Blueprint

Recent advances in the fields of genomics and proteomics are providing new ways to derive more valuable data for cancer
research from human biospecimens. Advances in informatics can now support the compilation and analysis of genetic and
clinical data on an unprecedented scale. Applications of genomic and informatic technologies to interrogate biospecimens
represent unparalleled opportunities for the discovery and development of new cancer diagnostic, therapeutic, and preventive
agents. For scientists to take full advantage of the power of new informatics tools to compare results across multiple
investigations requires genetic and clinical data to be available in a standardized format. In brief, to accelerate
discovery for cancer research, scientists need timely and equitable access to biospecimens that are annotated with
clinical information and collected specifically for genomic and proteomic studies, as well as a platform for comparing
analyses with the results of other researchers.

At the same time, the advanced technical capabilities that enable the linkage of genetic data with clinical information
have raised ethical, legal, and social concerns. Individual contributors of biospecimens and data for clinical research
must feel confident that the privacy of their medical information will be honored by the research community.

The National Biospecimen Network (NBN) provides a key infrastructure to harness the potential of new technologies for
cancer research, while ensuring that the privacy interests of biospecimen donors are preserved. It creates a comprehensive
framework for sharing and comparing research results through a robust, flexible, scalable, and secure bioinformatics system
that supports the collection, processing, storage, annotation, and distribution of biospecimens and data using standard
operating procedures based on best practices. This combination of characteristics is vital to fully support emerging
scientific opportunities to accelerate progress in prevention, diagnosis, and treatment of cancer.

The NBN concept represents an innovative approach to provide biological materials and clinical information to advance
translational research. Although many existing tissue repositories in the United States collect and store millions of
specimens for many types of scientific investigations, the contents of these repositories are frequently collected and
stored under varying conditions, making it difficult for scientists to compare or pool genomic and proteomic results from
biospecimens across institutions. Because many of these samples were initially collected for a broad range of uses, the
amount of clinical information associated with these biospecimens also varies widely, and is rarely detailed or longitudinal.
In addition, many of these biospecimens may not have appropriate donor authorization for genetic studies. Finally, current
access to existing specimens is often uneven, further impeding scientific progress.

The heterogeneity among existing repositories poses a challenge to support genomic and proteomic research, particularly
concerning the ability to conduct and compare large numbers of biospecimens to capitalize on genomic and proteomic technologies.
The NBN model is designed to standardize resources to overcome these obstacles. However, it should also build on existing
resources to function efficiently and cost effectively.

With the recognition that a national tissue resource, although ambitious, is necessary to realize the promise of genomics
and proteomics for the prevention and cure of cancer and other diseases, the National Dialogue on Cancer Tissue Access
Working Group, in collaboration with the National Cancer Institute, commissioned a Design and Engineering Blueprint for
an NBN (the "NBN Blueprint"), with the following goal:

"to establish a national, pre-competitive, regulatory compliant and genetic privacy protected, standardized,
inclusive, highest quality network of biological sample(s) banks; supported by and developed via novel financial and
other partnerships with cancer survivors and advocates, the private sector and nonprofit organizations as appropriate;
that is shared, readily accessible, and searchable using state-of-the-art informatics systems (e.g., amenable to
molecular profiling capability)."

The Design Team outlined essential requirements of the NBN and made specific recommendations. Taken together, these
requirements and recommendations provide a framework for realizing the vision of the NBN to be the first nationwide,
standardized biospecimen resource designed to facilitate genomic and proteomic research.